Oral ecnoglutide tablet History and Updates

34 events · 2021 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
34
Trial Milestones
0
Pivotal Publications
Oral ecnoglutide tablet — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications2022202320242025202620272028Trial: NCT07434050 2026-03-02 → 2028-06-19 (primary completion)Trial: NCT07387094 2026-02-09 → 2027-12-16 (primary completion)Trial: NCT07243171 2025-11-18 → 2026-08-03 (primary completion)Trial: NCT07143227 2025-08-25 → 2026-06-30 (primary completion)Trial: NCT07073417 2025-07-28 → 2027-02-27 (primary completion)Trial: NCT06335134 2023-07-14 → 2024-01-08 (primary completion)Trial: NCT05813795 2023-04-05 → 2024-06-20 (primary completion)Trial: NCT05680129 2023-01-10 → 2024-07-03 (primary completion)Trial: NCT05680155 2022-12-29 → 2024-06-12 (primary completion)Trial: NCT05184322 2022-04-12 → 2024-07-13 (primary completion)Trial: NCT05111912 2021-11-30 → 2022-11-16 (primary completion)today (2026-05-21)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-05-21Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Oral ecnoglutide tablet since 2021, drawn from openFDA, ClinicalTrials.gov, and PubMed.

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
A Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Part
Primary completion· ClinicalTrials.gov
A Study to Compare XW003 Injection and Semaglutide Injection in Chinese Adults With Obesity (SLIMMER-UP-SWITCH)
Primary completion· ClinicalTrials.gov
A Study of XW003 in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy
Primary completion· ClinicalTrials.gov
A Study of XW003 in Obese Participants With Obstructive Sleep Apnea Receiving Positive Airway Pressure Therapy

Past events

2026
Trial started· ClinicalTrials.gov
A Study of XW003 in Obese Participants With Obstructive Sleep Apnea Receiving Positive Airway Pressure Therapy
Trial started· ClinicalTrials.gov
A Study of XW003 in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy
2025
Trial started· ClinicalTrials.gov
A Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Part
Trial started· ClinicalTrials.gov
A Study to Compare XW003 Injection and Semaglutide Injection in Chinese Adults With Obesity (SLIMMER-UP-SWITCH)
2024
2023
Trial started· ClinicalTrials.gov
A Drug-Drug Interaction Study Between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin
Trial started· ClinicalTrials.gov
A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM
2022
Trial started· ClinicalTrials.gov
XW004 To Evaluate the Safety, Tolerability, PK, and PD of Oral Ecnoglutide Tablet in Healthy Adults
2021

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.